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Public Health Officials Call For FDA Black Box Warnings On Opioids and Benzodiazepines



These pharmaceutical classes have been responsible for an increasing number of overdose deaths, prompting a call for labels that “explicitly warn about a dangerous combination of medications.”

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February 25, 2016 | by Sarah Massey, M.Sc.

Health officials across the US are asking that the US Food and Drug Administration (FDA) add new warning labels to opioid and benzodiazepine drugs. These pharmaceutical classes have been responsible for an increasing number of overdose deaths, prompting a call for labels that “explicitly warn about a dangerous combination of medications.”

Those behind the call-to-action have posted an online petition – which currently includes signatures from physicians, researchers and academics – urging the FDA to change the warning labels on the prescription medications. The supporters are also requesting that the FDA provide mandatory medication guides that warn patients of the danger of combining opioids and benzodiazepines.

“We believe that this black box warning is a critical first step in raising awareness around the danger of co-prescribing these medications,” said Dr. Leana Wen, the City Health Commissioner for Baltimore. “We expect the agency will take this petition from front-line public health leaders very seriously, and have already had initial productive conversations with them.”

In 2013, 31 percent of all prescription drug-related deaths in the US could be attributed to benzodiazepine overdoses. During the same year, 71 percent of prescription overdose deaths were linked to opioid abuse.

The data presented in the document accompanying the petition stresses the risks of co-prescribing the two drug classes. The 18-page appeal also provides ways an additional black box warning could ensure the public is aware of these dangers.

“We are proposing a black box warning, not a ban on concurrent use,” said Wen. “It is critical that doctors are aware of the reduced margin of safety that happens when opioids and benzodiazepines are co-prescribed. We believe that the vast majority of co-prescription is unnecessary and a clear warning will complement other efforts to promote safe prescribing.”

Opioids are commonly prescribed for pain relief, with benzodiazepines being more effective at treating muscle spasms in those suffering acute pain. Benzodiazepines can also be prescribed for anxiety.

“The warning educates doctors so that they can provide the highest quality of care to patients,” said Wen. “It’s through warnings like these that many doctors learn about the risks associated with medications. For some drugs, black box warnings have led to dramatic declines in prescriptions. For others, they have improved understanding and monitoring for key adverse effect.

“Doctors and patients alike can act now. If you are a doctor, consider the risks when co-prescribing opioids and benzodiazepines, including of fatal overdose,” she said. “If you are a patient, ask why you need both medications. Can you replace one of them with another type of medication with less risk?”

Keywords: Opioids, FDA, Warning Label


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